ALITRETINOIN IFC 30 mg SOFT CAPSULES

Introduction

Package Leaflet:information for the user

Alitretinoin IFC 30 mg soft capsules EFG

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Alitretinoin IFC 30 mg soft capsules EFG and what is it used for
2. What you need to know before you take Alitretinoin IFC 30 mg soft capsules EFG
3. How to take Alitretinoin IFC 30 mg soft capsules EFG
4. Possible side effects

5 Storage of Alitretinoin IFC 30 mg soft capsules EFG

1. Contents of the pack and further information

1. What is Alitretinoin IFC 30 mg soft capsules EFG and what is it used for

The active substance of Alitretinoin IFC is alitretinoin. It belongs to a group of medicines known as retinoids, which are derived from Vitamin A. Alitretinoin IFC is available in two doses, which contain 10 mg or 30 mg of alitretinoin.

Alitretinoin IFC is used to treat severe chronic eczema of the hands in adult patients, which has not improved after any other topical treatment, including corticosteroids. Treatment with Alitretinoin IFC should be supervised by a specialist skin doctor (dermatologist).

2. What you need to know before you take Alitretinoin IFC 30 mg soft capsules EFG

Do not take Alitretinoin IFC:

• If you are pregnantor breast-feeding.
• If there is a possibility that you may become pregnant, you must follow the precautions of the “Pregnancy Prevention Programme”, see the section “Warnings and precautions”.
• If you have liver disease.
• If you have severe kidney disease.
• If you have high levels of fats in the blood(such as high cholesterol or elevated triglycerides).
• If you have an untreated thyroid disease.
• If you have very high levels of vitamin Ain the body (hypervitaminosis A).
• If you are allergicto alitretinoin, to other retinoids (such as isotretinoin), to peanuts, to soy or to any of the other components of this medicine (listed in section 6).
• If you are taking tetracyclines(a type of antibiotic).

If any of the above conditions apply to you, consult your doctor. You must not take Alitretinoin IFC.

Warnings and precautions

Pregnancy Prevention Programme

Pregnant women must not take Alitretinoin IFC

This medicine may seriously harm the baby (the medicine is considered "teratogenic") - it may cause serious abnormalities of the brain, face, ear, eyes, heart, and certain glands of the baby (thymus and parathyroid). It also increases the likelihood of spontaneous abortion. This can happen even if Alitretinoin IFC is taken only for a short period during pregnancy.

• Do not take Alitretinoin IFC if you are pregnant or if you think you may be pregnant.
• Do not take Alitretinoin IFC if you are breast-feeding. It is likely that the medicine will pass into your milk and may harm your baby.
• Do not take Alitretinoin IFC if you may become pregnant during treatment.
• Do not become pregnant during the month following the interruption of this treatment because the medicine may still be present in your body.

Women who may become pregnant are prescribed Alitretinoin IFC under strict rules. This is due to the risk of serious harm to the baby

These are the rules:

• Your doctor must explain to you the risk of harm to the baby - you must understand why you must not become pregnant and what you must do to avoid becoming pregnant.

• You must have discussed contraception (birth control) with your doctor. The doctor will give you information on how to avoid becoming pregnant. The doctor may refer you to a specialist for advice on contraception.

• Before starting treatment, your doctor will ask you to have a pregnancy test. The test must show that you are not pregnant when you start treatment with Alitretinoin IFC.

Women must use effective contraceptives before, during, and after taking Alitretinoin IFC

• You must agree to use at least one very reliable contraceptive method (e.g., an intrauterine device or a contraceptive implant) or two effective methods that work in different ways (e.g., a hormonal contraceptive pill and a condom). Discuss with your doctor which methods would be suitable for you.
• You must use contraceptives for one month before taking Alitretinoin IFC, during treatment, and for one month after stopping treatment.
• You must use contraceptives even if you do not have your period or if you are not sexually active (unless your doctor decides that it is not necessary).

Women must accept to have pregnancy tests before, during, and after taking Alitretinoin IFC

You must agree to have regular follow-up visits, ideally every month.

• You must agree to have regular pregnancy tests, ideally every month during treatment and, because the medicine may still be present in your body, one month after stopping treatment with Alitretinoin IFC (unless your doctor decides that it is not necessary in your case).
• You must agree to have additional pregnancy tests if your doctor asks you to.
• You must not become pregnant during treatment or during one month after treatment, because it is possible that the medicine may still be present in your body.
• Your doctor will discuss all these points with you, using a checklist, and will ask you (or a parent/guardian) to sign it. This checklist confirms that you have been informed about the risks and that you will follow the above rules.

If you become pregnant while taking Alitretinoin IFC, stop taking the medicine immediatelyand consult your doctor. Your doctor may refer you to a specialist for advice.

Also, if you become pregnant within one month after stopping Alitretinoin IFC, you must consult your doctor. Your doctor may refer you to a specialist for advice.

Advice for men

The levels of oral retinoids in the semen of men taking Alitretinoin IFC are too low to harm the baby of their partners. However, you must never share your medicine with anyone.

Additional precautions

Never give this medicine to another person. Please take any unused capsules to your pharmacist at the end of treatment.

Do not donate blood during treatment with this medicine, or for one month after stopping Alitretinoin IFC, because a baby may be harmed if a pregnant patient receives your blood.

Consult your doctor before starting Alitretinoin IFC:

• If you have ever had any mental health problems.This includes depression, aggressive tendencies, or mood changes. It also includes thoughts of self-harm or ending your life. This is because your mood may be affected while taking Alitretinoin IFC.
• If you have kidney disease.Alitretinoin IFC is not recommended in people with moderate kidney disease. If you have kidney disease, consult your doctor if Alitretinoin IFC is suitable for you.
• If you have high levels of fats in the blood;you may need to have blood tests more often. Alitretinoin IFC generally increases blood fats, such as cholesterol or triglycerides. If blood fats remain high, your doctor may reduce the dose or stop treatment with Alitretinoin IFC.
• If you have high blood sugar levels (diabetes);you may need to check your blood sugar levels more frequently, and your doctor may reduce the dose of Alitretinoin IFC.
• If you have had thyroid disease.Alitretinoin IFC may reduce thyroid hormone levels. If thyroid hormone levels are low, your doctor may prescribe supplements.

Be particularly careful during treatment:

• If you have any vision problems; inform your doctor immediately.You may need to stop taking Alitretinoin IFC and have your vision monitored.
• If you have persistent headache,nausea, or vomiting (feel like vomiting or vomit) and blurred vision, as these may be signs of a condition called benign intracranial hypertension. Stop taking the capsulesimmediatelyand contact your doctor as soon as possible.
• If you have bloody diarrhea. Stop taking the capsules immediatelyand contact your doctor as soon as possible.
• Reduce exposure to sunlightand avoid exposure to sunlamps. Your skin may become more sensitive to sunlight. Before exposing yourself to the sun, use a sunscreen with a high sun protection factor (SPF 15 or higher). If you experience dry skin and lips during treatment, use moisturizing creams or ointments and lip balm.
• Reduce intense physical activity.Alitretinoin may cause muscle and joint pain.
• If you develop dry eyes;you can relieve it by applying an eye lubricant ointment or artificial tears. If you wear contact lenses, you may need to wear glasses during treatment with alitretinoin. Dry eyes and vision problems usually return to normal when treatment is stopped.
• Alitretinoin IFC may increase liver enzyme levels.Your doctor will perform blood tests during treatment to check these levels. If they remain high, your doctor may reduce the dose or stop treatment with Alitretinoin IFC.

Mental health problems

• You may not notice some changes in your mood and behavior, so it is very important that you tell your friends and family that you are taking this medicine. They may notice these changes and help you identify any problems that you need to discuss with your doctor.

• If you develop any mental health problemsincluding depression, aggressive tendencies, mood changes, thoughts of self-harm, or ending your life, you must stop taking Alitretinoin IFC immediatelyand contact your doctor as soon as possible.

Children and adolescents

Alitretinoin IFC is not recommended for use in children under 18 years of age. The efficacy in this age group is unknown.

Taking Alitretinoin IFC with other medicines

Do not take other medicines that contain retinoids(e.g., isotretinoin), vitamin A supplements, or tetracyclines(a type of antibiotic) while taking Alitretinoin IFC, as this increases the risk of side effects.

Tell your doctor or pharmacist if:

• you are taking amiodarone(a medicine that helps regulate heart rhythm). It is not recommended to take amiodarone with Alitretinoin IFC.
• you are taking ketoconazole, fluconazole, miconazole(medicines used to treat infections). Your doctor may decide to reduce the dose of Alitretinoin IFC.
• you are taking simvastatin(a medicine used to lower cholesterol levels). Alitretinoin IFC may decrease the amount of this medicine in your body.
• you are taking gemfibrozil(another medicine used to lower cholesterol levels) or oxandrolone(an anabolic steroid). Your doctor may decide to reduce the dose of Alitretinoin IFC.
• you are being given paclitaxel(used to treat cancer), taking rosiglitazoneor repaglinide(used to treat diabetes). Alitretinoin IFC may increase the amount of these medicines in your body.

Tell your doctor or pharmacistif you are using, have recently used, or might use any other medicines, including those obtained without a prescription. This also includes herbal medicines.

Pregnancy, breast-feeding, and fertility

For more information on pregnancy and contraception, see the section “Pregnancy Prevention Programme” in the section “Warnings and precautions”.

Driving and using machines

Your vision may not be as good at night during treatment. If this happens, do not drive or operate machinery.

Alitretinoin IFC contains soybean oil

Do not use this medicine if you are allergic to peanuts or soy.

Alitretinoin IFC contains sorbitol

This medicine contains 25.55 mg of sorbitol in each Alitretinoin IFC 30 mg capsule.

3. How to take Alitretinoin IFC

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

When to take the capsules

The capsule should be taken with a main meal, preferably at the same time each day. The capsules should be swallowed whole and not chewed.

How much to take

The dose is 10 or 30 mg once a day. If your body cannot tolerate the recommended dose of 30 mg, you may be prescribed the lower dose of 10 mg.

How long to take the capsules

A treatment cycle usually lasts between 12 and 24 weeks, depending on how the disease improves. If your first treatment is successful, your doctor may prescribe another treatment cycle if symptoms recur.

If you take more capsules than you should

If you take too many capsules or if someone else accidentally takes your medicine, contact your doctor, pharmacist, or go to the nearest hospital immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20. It is recommended to take the package and the leaflet of this medicine to the healthcare professional.

If you forget to take Alitretinoin IFC

If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, do not take the missed dose and continue as before. Do not take a double dose to make up for missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common Effects(may affect more than 1 in 10 people)

• Headache.
• Increased blood fats: higher levels of fats (triglycerides) and cholesterol in the blood.

Common Effects(may affect up to 1 in 10 people)

• Blood cell disorders:increase in the number of blood platelets (cells that help with clotting), decrease in the number of red and white blood cells observed in blood tests.
• Thyroid problems:decrease in thyroid hormone levels.
• Eye problems:eye inflammation (conjunctivitis) and eyelid area, with dryness and irritation in the eyes.

?Ask a pharmacist for a suitable eye drop. If you wear contact lenses and suffer from dry eyes, you may need to wear glasses instead.

• Ear problems:persistent ringing in the ears (tinnitus).
• Dizziness.
• Blood and circulation disorders:hot flashes, high blood pressure (hypertension).
• Intestinal and stomach problems:nausea, vomiting, dry mouth.
• Muscle and joint pain:muscle pain, joint pain, lack of energy (fatigue). High levels of muscle breakdown products in the blood if you engage in strenuous exercise.
• Skin and hair problems:dry skin, especially on the face, dry and inflamed lips, skin redness, itchy rash, inflamed skin, hair loss.
• Liver problems:elevated liver enzymes observed in blood tests.

Uncommon Effects(may affect up to 1 in 100 people)

• Vision problemsincluding blurred vision, distorted vision, cloudy surface in the eye (corneal opacity, cataracts).

??If your vision is affected , stop taking Alitretinoína IFC immediatelyand contact your doctor.

• Skin problems:skin itching, skin peeling, rash, dry skin eczema.
• Ear, nose, and throat problems:nosebleeds.
• Intestinal and stomach problems:indigestion (dyspepsia).
• Bone disorders:excessive bone growth, including a spinal disorder called ankylosing spondylitis.

Rare Effects(may affect up to 1 in 1,000 people)

• Persistent headache, with general discomfort (nausea), vomiting, and changes in vision, including blurred vision. This may be a sign of benign intracranial hypertension.

??If you experience these symptoms, stop taking Alitretinoína IFC immediatelyand contact your doctor.

• Blood and circulation disorders:inflammation of blood vessels.
• Skin and hair problems:nail changes, increased skin sensitivity to sunlight, changes in hair texture.

Mental Problems

Rare Effects(may affect up to 1 in 1,000 people)

• Depression or related disorders.These signs include sad or altered mood, anxiety, feelings of emotional distress.
• Worsening of existing depression.
• Becoming violent or aggressive.

Very Rare Effects(may affect up to 1 in 10,000 people)

• Some people have had feelings or thoughts about self-harm or ending their own lives (suicidal thoughts), have attempted to end their own lives (suicide attempt), or have ended their own lives (suicide). These people may not seem to be depressed.
• Unusual behavior.
• Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that are not there.

Contact your doctor immediately if you experience signs of any of these mental problems.Your doctor may advise you to stop taking Alitretinoína IFC. This may not be enough to stop the effects: you may need more help, and your doctor can manage it.

Other Adverse Effects

In a very small number of people, other adverse effects have occurred, whose exact frequency is unknown:

Severe Allergic Reactions

The signs include:

• itchy raised rash (hives).
• inflammation, sometimes of the face or mouth (angioedema), causing difficulty breathing.
• collapse.

??If you have these symptoms, contact your doctor immediately. Stop taking Alitretinoína IFC.

Intestinal and Stomach Disorders

Severe stomach pain (abdominal) with or without bloody diarrhea, general discomfort (nausea), and vomiting.

??Stop taking Alitretinoína IFC immediatelyand contact your doctor. This may be a sign of serious intestinal conditions.

Night Vision Problems

Vision problems usually return to normal after stopping treatment.

Blood and Circulation Disorders

Swelling of the hands, lower legs, and feet (peripheral edema).

Adverse Effects of Other Medicines in the Same Class as Alitretinoína IFC

These effects have not been observed with Alitretinoína IFC to date, but they cannot be ruled out.

They are very rare and may affect less than 1 in 10,000 people.

Diabetes

Excessive thirst, frequent need to urinate, blood tests showing an increase in blood sugar levels.

All of these can be signs of diabetes.

Bone Disorders

Arthritis, bone disorders (growth delay, changes in bone density). Growing bones may stop growing.

Eye and Vision Changes

Worsening of color blindness and color vision, intolerance to contact lenses.

In rare cases, soybean oil can cause severe allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Alitretinoína IFC

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Alitretinoína IFC

• The active ingredient is alitretinoin.

Each soft capsule contains 30 mg of alitretinoin.

-The other ingredients are:

Capsule content: refined soybean oil, partially hydrogenated soybean oil, hydrogenated vegetable oil, glycerol monostearate, medium-chain triglycerides, all-rac-α-tocopherol.

Capsule shell: gelatin, glycerol, non-crystallizing sorbitol liquid (E420), titanium dioxide (E171), purified water, and yellow iron oxide (E172).

Product Appearance and Packaging Contents

Alitretinoína IFC 30 mg soft capsules are oval, yellow, 13 mm x 8 mm, and contain a viscous, opaque, yellow-orange suspension.

The capsules are packaged in PVC/PVDC/Aluminum blisters.

Package size: 30 capsules.

Marketing Authorization Holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Manufacturer

Industrial Farmacéutica Cantabria, S.A.

C/ Pirita, 9

28850 Torrejón de Ardoz (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area under the following names:

Netherlands: ALITRETINOÏNE IFC 30 mg capsules, soft

Spain: Alitretinoína IFC 30 mg soft capsules EFG

Italy: ALITRECARE

Portugal: ALITRETINOÍNA CANTABRIA 30 mg soft capsules

Date of the last revision of thisprospectus:April 2021

Detailed andupdatedinformation about this product is available by scanning the QR code included in the prospectus using a smartphone. The same information is also available at the following link:http://www.aemps.gob.es